Samer M. Najjar

Biography

M.Sc. Pharmaceutical technology, with focused research on transdermal drug delivery system and drug release from sustained release matrices. 19 years of experience in pharmaceutical research. 7 Years of them as R&D manager at Joswe medical and responsible for development their pipeline. Extensive knowledge and experience of analytical methods development, validation, Pre formulation, stability testing, and scaling up of products. Extensive knowledge and experience of regulatory filing including CTD dossiers preparation and response to regulatory inquiries. Good knowledge of IPR issues related to formulation and registration processes. Extensive knowledge of pharmacokinetics related to drug development and conduction of bioequivalence studies, with solid experience in monitoring and auditing of bioequivalence studies and CRO’s. Good knowledge and experience in cGMP and site inspection. Member of JFDA committees for quality control and site inspection/approval.

Research Interest

Pharma, Clinical research